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Historical Background of FDA and U.S. Food and Drug Law – Paul Hyman, Hyman, Phelps & McNamara, PC, Washington, D.C.

Organization of FDA and Its Regulatory Tools – Fred H. Degnan and Smitha Stansbury, King & Spalding, LLP, Washington, D.C.

The Philosophy of Food and Drug Law and FDA’s Regulatory Authority – Benjamin M. Greenblum, Williams & Connolly LLP, Washington, D.C.

Overview of the U.S. Legal System – Edward P. Richards, III, Louisiana State University Law Center, Baton Rouge, LA

Overview of FDA Enforcement Authority – Vernessa T. Pollard and Anisa Mohanty, McDermott Will & Emery, LLP, Washington, D.C.

Regulation of Drugs, Biologics, Controlled Substances, Cannabis, and Compounded Drugs – Marc J. Scheineson, Brendan M. Carroll, and Benjamin K. Wolf, Alston & Bird LLP, Washington, D.C.

Pharmacovigilance Requirements for Drugs and Biologics – Edward John Allera, Genevieve M. Spires, Tina Hu-Rodgers, and Matthew Piscitelli, Buchanan Ingersoll & Rooney PC, Washington, D.C.

Regulation of New Animal Drugs – Jay W. Cormier, Levo Therapeutics, Inc., Skokie, IL

Regulation of Medical Devices – Stephen M. Kanovsky, GE Healthcare, Marlborough, MA; Edward C. Wilson, Jr. and Michael S. Heyl, Hogan Lovells US LLP, Washington, D.C.

Regulation of Combination Products – Paula Burge, Dorothy Henckel, and Miles Johnson, Guidehouse, Chicago, IL

Regulation of Promotion and Marketing for Medical Products – Wayne L. Pines, APCO Worldwide Inc., Washington, D.C.

Regulation of Foods, Food Additives, and Food Biotechnology – Daniel A. Kracov, Raqiyyah R. Pippins, Pari R. Mody, and Elizabeth Trentacost, Arnold & Porter, Washington, D.C.

Regulation of Dietary Supplements – James William Woodlee, Cynthia L. Meyer, and Justine E. Johnson, Kleinfeld, Kaplan & Becker, LLP, Washington, D.C.

Regulation of Cosmetics – Thomas F. Myers, Personal Care Products Council, Washington, D.C.

Regulation of Tobacco and Nicotine Products – J. Ben Haas, Nathan Beaton, and Daniel W. Bernal, Latham & Watkins LLP, Washington, D.C.

Regulation of Research – Gary L. Yingling and Ann M. Begley, Wiley Rein LLP, Washington, D.C.

FDA Inspections and Related Regulations – Ronald F. Tetzlaff, Parexel International LLC, Duluth GA; David L. Chesney, DL Chesney Consulting, LLC, Cumberland Foreside, ME

Managing an FDA Regulatory Crisis – Wayne L. Pines, APCO Worldwide, Washington, D.C.

International Food and Drug Regulation – John Balzano, Covington & Burling LLP, New York, NY; Peter Bogaert, Covington & Burling LLP, Brussels, Belgium; Sam Halabi, The University of Missouri School of Law, Columbia, MO; Richard Kingham, Covington & Burling LLP, Washington, D.C.